WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM— 510(k) K953000

Name: FDA 510(k) clearance K953000
Creator: U.S. Food and Drug Administration
Published: 1995-10-31

Substantially Equivalent

Implant Center of the Palm Beaches

FDA 510(k) clearance K953000 for WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM, Substantially Equivalent on 1995-10-31. Applicant: Implant Center of the Palm Beaches. Device class: 2.

Clearance details

Applicant: Implant Center of the Palm Beaches
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1995-06-23
Decision date: 1995-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Palm Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K952985 — WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS1995-10-31
K952991 — WIDE SCREW HA-5B, CYL-HA-51995-10-31
K952992 — PROSTHETICS 4MM1995-10-31
K952994 — TP-4 WIDE CYLINDER IMPLANTS1995-10-31
K952996 — HA/TP COATED CYLINDER IMPLANT 3.3,4.01995-10-31

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.